Role & responsibilities Job responsibilities comprise carrying out of Quality Assurance functions in day-to-day activities. JOB RESPONSIBILTY1. Responsible for review, approvals and close outs of change controls, deviations, CAPA, incident reports and any other quality system documents 2. Develop, manage and improve Quality Systems and procedures to ensure compliance with all applicable laws, regulations and company quality standards in support of CGxP activities 3. Review and approvals of analytical and formulation development Master documents. 4. Review and approval of analytical activities protocols and reports 5. Submitting whole set of documents required for regulatory submissions for new products 6. Supporting for any regulatory queries from QA perspective 7. Review and approval of validation, qualifications protocols and reports,8. Monitoring day to day activities in Analytical development and Formulation development in compliance to the GMP9. Preparation, review and approval of SOPs 10. Conducting training on SOPs, quality management systems and GMP in all aspects including procedural updates 11. Control of documents includes documents storage, issuance, distribution, retrieval and destruction 12. Performing vendor audits of API and Excipients (where necessary) and handling of all activities related to vendor audits 13. Conduct periodic audits of CMOs and Althera affiliate facilities. Participate in the vendor Qualification programme as and when needed.14. Review and approve change control initiated at CMOs and co-ordination with European QA, RA aid customers and keep track till all the relevant activities are completed15. Planning and conducting of self-inspection, preparing and sending self-inspection reports to concerned departments. Verifying the self-inspection compliance report for correctness and completion 16. Oversight and coordination with the Contract Manufacturing Organization (CMOs) on batches manufacturing activities as well Quality Management functions for Althera products 17. Coordination with the European QA team on supplying necessary QMS documents as required18. Responsible for review, approvals and close outs of deviations, CAPA, OOS, OOT and incident reports raised by the CMOs. Timely review of effectiveness of CAP As.19. Participate in investigations at the CMOs where necessary, review and ensure the investigations are conducted in line with the current regulatory expectations.20. Applying risk management tools wherever applicable in accordance with current regulatory requirements 21. Handling of Market complaints and to co-ordinate with respective CMOs to get the investigation done on timely manner with appropriate root causes and CAPAs identified.22. Track all the QMS status of Althera products at CMOs are timely concluded, and reports are shared23. Coordinate with CMOs in any Regulatory and customer audits at their site, track all the observations and the CAPAs are completed timely as per the commitment. 24. Review and approve of CMOs validation and master documents (BMRs, BPRs, MFR, PVPs, PVRs etc) and Protocols (Validation, Qualification, cleaning, stability etc)25. Oversee, support and coordinate with Althera affiliate manufacturing and Testing sites and the RnD site. 26. Preparation, Review of the PQRs for Althera products. 27. Ensure quality / technical agreements with contract manufacturing organizations (CMOs)are available and updated within timelines. Preferred candidate profile Perks and benefits best in the industry

Role & responsibilities: To handle cleaning validation activities. (MACO calculation, product and equipment matrix preparation, grouping, sampling location/ analytical method updating in software as well as manually.Preparation of cleaning validation, cleaning verification, cleaning study protocols and report compilation. Evaluation of newly introduced equipment/product with respect to cleaning validation master plan (Bracketing) for cleaning validation and cleaning verification requirements. Various cleaning study execution with respect to change in cleaning agent/cleaning procedure. Annual Cleaning process review report preparation for evaluation of cleaning process/ Change Control/ Deviation/ New product introduction/ New equipment introduction not limited to. Protocol preparation, execution and report compilation of DEHT/CEHT/recovery study for various equipment and to evaluate gap assessment in cleaning validation SOP. To support Process validation and Hold time study activitiesExecution in duct cleaning validation/ verification activities with CFTIdentification of Hard to clean locations of equipment with production team. Identification of worst case products and calculation of swab limits. Determination of Visual residue limit by protocol based study.To involve in investigations / failures related to cleaning methodologies. Preferred candidate profile: Well-versed with Cleaning Validation activities in OSD mfg. site.Sharp in Documentation and Review of shopfloor dataGood communication and interpersonal skills EU/ TGA/ ANVISA regulatory audit exposure is an advantageGood knowledge of European agency guidelines Sound knowledge of ALCOA+ concepts and able to identify gaps w.r.t. ALCOA+ principles if any at shopfloor operations.Strong analytical and problem-solving skillsAttention to detail and ability to work under pressureKnowledge of the local language (Kannada) is an added advantage Perks and benefits:Best in industry

Position - Project Manager (IC role- To confirm) Job DescriptionAlthera Laboratories India private Limited is a leading OSD (Oral Solid Dosage) manufacturing company committed to developing and delivering innovative pharmaceutical products. We are seeking a highly motivated and experienced Project Manager to lead and drive all the activities from Product development till dossier filing for our drug development pipeline.Job Responsibilities: -Develop and execute comprehensive the project plans, timelines, in alignment with company objectives and regulatory requirements.Align with Organisational objectives in product launch and proactive act on the sameCollaborate with customers to understand their requirements, and align the organisational support to the same and efficiently communicate back with customersOversee and drive all aspects of Project execution starting from Product development, manufacturing at GMP unit, Validation batches, support for Regulatory filing etc. Collaborate effectively with cross-functional teams, including R&D, Manufacturing, regulatory affairs and Quality Assurance to achieve project milestones.Build and maintain strong relationships with key stakeholders from all the relevant departments. Monitor and manage project timelines, and resources effectively.Identify and mitigate project risks proactively. Required Qualifications: - Advanced degree in life sciences, pharmacy, or a related field.06 to 15 years of experience in Project Management within the pharmaceutical industry, preferably from OSD background.Proven track record of successful Project Management from initiation to completion.Proactively manage project risks, develop mitigation strategies, and communicate effectively to project teams and managementStrong leadership and interpersonal skills with the ability to build and motivate cross-functional teams. Preferred Qualifications: -Knowledge of global regulatory requirements (EUGMP).Perks and benefits: - We offer a competitive salary (best in industry), comprehensive benefits package such as Bonus, and opportunities for professional growth and development.